PRECISION GRX Registry

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT03278301
• Lead Sponsor: Corindus Inc.

Brief Summary

To collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath GRX System, in the delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures.

Detailed Description

This is a single-arm, open-label, multi-center patient registry of the CorPath GRX System to examine its performance during PCI procedures and patient outcomes through 72 hours post-procedure or hospital discharge, whichever occurs first.

Study Timeline

• Study Start: 2017-08-27
• Study First Submitted: 2017-09-06
• Study First Submitted QC: 2017-09-07
• Study First Posted: 2017-09-11
• Primary Completion: 2020-02-06
• Study Completion: 2020-02-06
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-15
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 952

Inclusion Criteria

Candidates will be included in the study only if all of the following conditions are met:

1. Age ≥18 years;
2. Patients with coronary artery disease with clinical indication for PCI;
3. Patient deemed appropriate for robotic-assisted PCI; and
4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria

• Candidates will be excluded from the study if any of the following conditions are present:

  1. Failure/inability/unwillingness to provide informed consent; or
  2. The investigator determines that the patient or the coronary anatomy is not suitable for robotic-assisted PCI.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Success	Discharge or 72 hours post intervention, whichever comes first.	Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the CorPath GRX System, without in-hospital major adverse coronary events (MACE).
Technical Success	Procedure	Defined as successful completion of the robotic-assisted PCI absent unplanned conversion to manual for guidewire or balloon/stent catheter inability to navigate vessel anatomy or poor guide catheter support.

Secondary Outcome Measures

Name	Time	Method
Overall Procedure Time	Procedure	Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
Fluoroscopy Time	Procedure	Total Fluoroscopy Time during procedure will be captured.
Patient Radiation Exposure	Procedure	DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure.
PCI Procedure Time	Procedure	Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.

Trial Locations

Locations (20)

UC San Diego Health Sulpizio Cardiovascular Center; 🇺🇸 San Diego, California, United States

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Spectrum Health Hospitals Fred and Lena Meijer Heart Center; 🇺🇸 Grand Rapids, Michigan, United States

William Beaumont Hospital - Troy; 🇺🇸 Troy, Michigan, United States

St. Luke's Hospital of Kansas City; 🇺🇸 Kansas City, Missouri, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States

New York-Presbyterian Columbia University Medical Center; 🇺🇸 New York, New York, United States

WakeMed Raleigh Campus; 🇺🇸 Raleigh, North Carolina, United States

Einstein Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Wellspan York Hospital; 🇺🇸 York, Pennsylvania, United States

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